Basic NaturalsTY 5742 WEST HAROLD GATIY DRIW SALTLAKECITY;, U l XNll~~ : )- ; Phone Fax
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1 Basic NauralsTY LLC 5742 WEST HAROLD GATIY DRIW SALTLAKECITY;, U l XNll~~ : )- ; Phone Fax : December 29,2004 VIA: Cerified Mail Food and Drug Adminisraion 200 C Sree S.W. Washingon, DC Re: Noificaion Pursuan o Secion 6 of DSHEA and 2 CFR $0.93 Dear Sir or Madam: Enclosed please find he Noificaion Pursuan o Secion 6 of DSHEA and 2 CFR $0.93 for he dieary supplemen produc Sim-FreeTM. This noificaion is on behalf of Basic NauralsTM, LLC. Please review he informaion a your earlies convenience. Please conac me wih my quesions or if here is any furher informaion I can provide regarding his maer. Sincerely, Enclosure Heaher Sprik Legal Assisan LEI / s 0 9 0
2 , # *.. &&i NOTIFICATION PURSUANT TO SECTION 6 OF DSHEA AND 2 CFR This noificaion is being filed on behalf of Basic NauralsrM ) LLC ha is he Disribuor of he produc(s) which bear he saemens idenified in his noificaion. Is business address is: 5742 W Harold Gay Dr, Sal Lake Ciy, Uah 846. This noificaion is being made pursuan o Secion 6 of DSHEA and Rule 2 C.F. R The dieary supplemen produc on whose label or labeling he saemens appear is Sim-FreeTM. The ex of each srucure-funcion saemen for which noificaion being given is: is now (Saemen ): (Saemen 2): (Saemen 3): (Saemen 4): (Saemen 5): (Saemen 6): (Saemen 7): (Saemen 8): (Saemen 9): Rapid Fa Loss Produces Rapid Loss of Excess Body Fa. Produces Rapid Increase in Energy Levels. Clinically Proven Fa Burner. In an exraordinary, double-blind, placebo conrolled clinical sudy, 20 overweigh men and women were divided ino hree groups. Group A received he acive Phophoserine TM Rapid Fa Loss Formula complex, Group B received a placebo, and Group C aced o as a conrol (received nohing). Each group was insruced o follow a saisfying 800 calorie meal plan and modes 3-day per week exercise program. Group A (he group aking he Simulan-Free Rapid Fa Loss Formula Phophoserine complex) experienced significan decrease in overall body weigh. In fac, he loss of body weigh was more han 8 imes greaer han he group who simply followed he die and exercise program alone. Even more sarling was he fac ha he average loss of acual body fa in he Simulan-Free Phophoserine complex group was jus shor of en pounds! Tha s a loss of acual body fa 62% greaer han he placebo group and 63% greaer han he conrol. The Simulan-Free Phophoserine complex group experienced a marked reducion in faigue levels and fel 32% more energeic. Finally, here s a 00% simulan-free, clinically proven way o lose excess pounds of deep spongy fa and flab.
3 *.. c 2 c The following summary idenifies he dieary ingredien(s) or supplemen(s) for which a saemen has been made: Saemen Ideniy of Dieary Ingredien(s) or Supplemen(s) Number ha is he Subjec of he Saemen: Sim-Free - 8Oc Bole 2 Sim-FreeTM - 8Oc. Bole 3 Sim-FreeTM - 8Oc. Bole 4 Sim-FreeTM - 8Oc. Bole 5 Sim-FreeTM - 8Oc. Bole 6 Sim-FreeTM - 8Oc. Bole 7 Sim-FreeTM - 8Oc. Bole 8 Sim-FreeTM - 8Oc. Bole 9 Sim-FreeTM - 8Oc. Bole The following idenifies he brand name of each supplemen saemen is made: for which a Saemen Number Brand Name Label or Labelinsr? Basic NauralsTM, LLC Basic NauralsTM, LLC Basic NauralsTM, LLC Basic NauralsTM, LLC Basic NauralsTM, LLC Basic NauralsTM, LLC Basic NauralsTM, LLC Basic NauralsTM, LLC, Basic NauralsTM, LLC I, Daniel B. Mowrey, Ph.D., am auhorized o cerify his Noificaion on behalf of Basic Naurals TM, LLC. I cerify ha he informaion presened and conained in his Noificaion is complee and accurae, and ha Basic NafuralsTM, LLC has subsaniaion ha each srucure-funcion saemen is ruhful and no misleading. Daed hi&ay of,;&fl*,2004. Consulan o Basic Nafuralsm, LLC
4 Supplemen Facs Se&a S&s: 2 capsules Uamin 63 (niacin) 20mq 00% Phosphoserine a proprieary blend conaining: 33mg Calcium (as calofum Phosphae) nag 7% Commiphora mukul SE &uanle cambogii SE WA 25mg) L-Tyrosine Phosphorus (as mono & diiodium, 9mg 2% dipoassim & c&urn phosphae) Poassdum (as dipoassiun phosphae 67mg 2% Sod$n~~ mono & disodium 39mg 2% P P ) PhoafWidvlcbofine Wellaria baicalensis (roo) SE Suoleumm chlnense roeb SE Epimedium brevimrum (hem) SE $Percen Daily Values are based on a 2,000 calorie die Dailv Value no esablished Oher Inaredisns Rice Flour Dishibued by: Cwiomer Service Dieribuion Cener SaLakeGhy,UT646*--53 Fa Loss Componens: Combinaion of Calcium, Phosphae, L-Tymsfne, Commlphora Mukul, Garcmia Camboqiand Phosphaidylchoine. Proeced by US Paen No. 6,3,949 This produc is manufacured o be wihin all &epable induaby Variincea. Sandardized Exrac (SE) means an exracion process providing he highes qualiy compound manufacured o accfrpabie indusry variam%a. Manuacured in he U.S.A. ~.BASICNATURALS.COlTl Direcions: Take 2 capsules wih a full glass of waer hree imes a day as a dieary supplemen. You may ake Sim-Free wih or ihou food. Do no exceed recommended serving. %TIMULANT-FREE~~ APID FAT Loss* In an exraordmary, double-blind, placebo conrolled clinical sudy, 20 overweigh men and women were divided ino hree groups Group A received he acive PhosphoserineTM Rapid Fa Loss Formula complex, Group B received a placebo, and Group C aced as a conrol (received nohing). Each group was msroced o follow a saisfying 600 caforre meal plan and modes 3-day per week exercise program. Af?er only 6 weeks, he verified resuls were asbundliiq! Group A (he group aking he Simulan-Free Raprd Fa Loss Formula Phosphoserine complex) experienced a significan decrease m overall body we~qh In fac, he loss of body weigh was more han 6 imes greaer han he group who srmply followed he die and exercise program alone. Even more sarlng was he fac ha he average loss of acual body fa a he Sbmulan-Free Phosphoserine complex group was ]us shor of 0 pounds!+ Tha s a loss of acual body fa 62% greaer han he placebo group and 63% greaer han he conrol. Bu here s more. The Simulan-Free Phosphoserine complex group experienced a marked reducion in faigue levels and fel 32% mow energec. Wha else does his scienbfrcally validaed clrnical rial confirm? Smpiy his, Finally, here s a 00% simulan-free, cknicaly proven way o lose excess pounds of deep spongy fa and flab.
5 *. CAN T q OVERWEIGHT? TOLERATE STIMULANT-BASED DIET PILLS? TAKE THE STlM-FREE RAPID FAT Loss QUIZ! Do die pills conaining nervous or uncomforable? simulans make you jiery, q Have you been looking for a simulan-free, clinically proven, safe, fas and effecive fa-loss produc? 0, q Do you wan o jumps&y your die wrhou jumpsarhng cenral nervousysem jiers? Do you wan fas. vrsible resuls everyone will noice - wihou nervousness, dry mouh, or insomnia? q Would you jump a a chance o ge a produc produces raprd fa loss, increases energy, and ha makes you feel good wihou harsh simulans? IF YOU ANSWERED YES TO ANY ONE OF THESE QUESTIONS, THEN STEM-FREE MAY SE THE PERFECT FAT-LOSS FORMULA FOR YOU! No for use by individuals under 8 years of age unless direced by a docor. lnemaonal disribuion IS no auhorized wihou prior wrien consen Produc resale allowed only hrough auhorized represenaives. Before slaring his or any weigh-conrol program, check wrh your healh-care provider o make sure you are m overall good healh. I your healh-care provider has any quesions, please have him or her call l 'These S~ie8l~~ have IlO bu?bn evab&d by he Food and DN# AUmlnialrainn. lbls pmduo is no inended o diignase, rea, ours, 2004 Basic Naurals, LLC BR87B DiETARY SUPPLEMENT 80 CAPSULES
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